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news.EMD Serono, an affiliate of Merck KGaA, has said that the US Food and Drug Administration (FDA) has extended its review period for Cladribine tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to 28 February 2011.
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EMD Serono‘s oral formulation of cladribine (Cladribine tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS).
Earlier, the FDA granted Priority Review status for Cladribine tablets in July of 2010, reducing the standard 10-month review period to six months, which was set to end on 28 November 2010.
The FDA has extended the review period to provide additional time for a full review of additional information provided under the new drug application (NDA).
Merck Serono Global Research and Development head Bernhard Kirschbaum said that EMD Serono continues to work closely with the FDA during the review process of the Cladribine tablets new drug application.
"We will continue working towards our goal of providing an oral disease-modifying drug for the treatment of relapsing multiple sclerosis," Kirschbaum said.